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RESIN Research Support Information Network(RESIN)
Presented by: Office of the Vice Chancellor for Research Date: May 1, 2018
Agenda
Updates & Timely Information from Research Support: Office of the VCR Biomedical Informatics
RSC ORISIRB ORCIACUC DLAMBiosafety ORRA
UAMS Library TRICore Facilities URC
25/1/2018
Arkansas Community Researcher Training (ArCRT)Amy Jo Jenkins, MS, Executive Director, TRI
ArCRT is a human research protection training program designed for community research partners who do not have a background in or experience with research or research ethics.
Like CITI Training!
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ArCRT is based on the training called CIRTification-Community Involvement in Research developed by Emily E. Anderson at The University of Illinois at Chicago Center for Clinical and Translational Science.
Also designed with feedback from graduates from TRI’s Community Scientist Academy (reviewed beta version and focus group).
Final product the collaborative effort of TRI, ORC, CON, Myeloma Institute, and OED.
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Arkansas Community Researcher Training (ArCRT)Amy Jo Jenkins, MS, Executive Director, TRI
Training Consists of 5 Lessons Introduction History of Research Abuses Rules and Regulations Informed Consent Privacy and Confidentiality
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Arkansas Community Researcher Training (ArCRT)Amy Jo Jenkins, MS, Executive Director, TRI
Training modules will be housed on Blackboard and accessed externally using GoSignMeUp.
Participants will be able to print a certificate at the end of the training.
Certificate can be uploaded into CLARA as proof of Human Subjects Protection training.
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Arkansas Community Researcher Training (ArCRT)Amy Jo Jenkins, MS, Executive Director, TRI
Training is good for 3 years.
Tracked by Office of Research Compliance.
Modules will be ready to use at the end of May 2018. Look for it in the TRI Announcements!
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Arkansas Community Researcher Training (ArCRT)Amy Jo Jenkins, MS, Executive Director, TRI
5/1/2018 8
Arkansas Community Researcher Training (ArCRT)Amy Jo Jenkins, MS, Executive Director, TRI
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Arkansas Community Researcher Training (ArCRT)Amy Jo Jenkins, MS, Executive Director, TRI
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Arkansas Community Researcher Training (ArCRT)Amy Jo Jenkins, MS, Executive Director, TRI
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Arkansas Community Researcher Training (ArCRT)Amy Jo Jenkins, MS, Executive Director, TRI
Questions?
Amy Jo Jenkins – TRI – ajjenkins@uams.edu Darri Scalzo – ORC – DLScalzo@uams.edu
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Arkansas Community Researcher Training (ArCRT)Amy Jo Jenkins, MS, Executive Director, TRI
DEA Audits of Researchers Darri Scalzo, Research Compliance Officer Kim Murphy, IACUC Compliance Analyst
DEA Unscheduled Audits Recent number of unscheduled DEA audits of
research registrants at UAMS and ACRIAny registrant using controlled substances in
research is eligible for an audit.UAMS Office of Research Compliance is not
notified in advance.Audits focus on recordkeeping, purchase, storage,
and usage of controlled substances.
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DEA Unscheduled Audit Process Biennial Inventory
Must be completed at least every 2 years.Snapshot in time of compounds and amounts on
hand.Must be updated if new compounds are received. This is the likely starting point for DEA Audit.Considered a violation if not current (dated within
past 2 years).
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DEA Audits of Researchers Darri Scalzo, Research Compliance Officer Kim Murphy, IACUC Compliance Analyst
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DEA Audits of Researchers Darri Scalzo, Research Compliance Officer Kim Murphy, IACUC Compliance Analyst
CONTROLLED SUBSTANCES BIENNIAL INVENTORY (to be completed at least every 2 years)
INVESTIGATOR NAME: ______________________________________________________________ DEA LICENSE #: _____________________________________________________________________ DATE: _________________________________ TIME: __________________________ BEGINNING or END of BUSINESS (e.g. before or after any experiments that day): ________________
DRUG NAME STRENGTH
(e.g. xx mg/ml) FORM
(e.g. liquid or powder)
UNITS (e.g. 10 ml vials, 100 mg bottle)
BALANCE ON HAND
INITIALS
DEA Unscheduled Audit Process Usage Logs
Must maintain usage logs for both stock concentrations as well as prepared solutions.
Running balance must be kept up to date. Balance will be compared to actual amounts on hand and to biennial inventory. Records must reconcile.
Must account for all usage and any losses or waste.Records must be kept for any expired or unwanted
compounds sent for destruction/disposal.
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DEA Audits of Researchers Darri Scalzo, Research Compliance Officer Kim Murphy, IACUC Compliance Analyst
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UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES NON-HUMAN USE OF CONTROLLED SUBSTANCES
CONTROLLED SUBSTANCES CONTINUING RECORD USE LOG Drug Name: ____________________________ Lot/Serial # _______________ Schedule (I-V): __________ Expiration Date: _________________ Form: ___________________ Strength/Dosage: __________ Initial Quantity/Volume _________ Lab Assigned Tracking # _________________ One log sheet must be completed for each container of Controlled Substance. If the material is converted or diluted, start a new log form to track that usage, reference the original container’s lot or serial # and original lab assigned tracking #.
Date Quantity Dispensed
Quantity Wasted
Balance Initials If Wasted Secondary
Verification Initials
Notes
*Explain all discrepancies between Expected Amount and On-hand amounts. If necessary report loss/theft.
DEA Audits of Researchers Darri Scalzo, Research Compliance Officer Kim Murphy, IACUC Compliance Analyst
DEA Unscheduled Audit Process Purchasing records
Must maintain copies of purchasing records for minimum of 2 years.
For Schedules I & II compounds, all sections of each Form 222 must be complete.
Purchased items must be reflected in your usage logs.
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DEA Audits of Researchers Darri Scalzo, Research Compliance Officer Kim Murphy, IACUC Compliance Analyst
DEA Unscheduled Audit Process Destruction/Disposal process
Contact Darri Scalzo or Kim Murphy if you have expired or unwanted controlled substances.
Appointment will be made to complete required paperwork and collect the items.
Copy of completed paperwork needs to be kept with your records.
Notation will be made on usage/inventory logs.
5/1/2018 19
DEA Audits of Researchers Darri Scalzo, Research Compliance Officer Kim Murphy, IACUC Compliance Analyst
Storage of controlled substances Must match what the DEA approved in your
license application. All controlled substances must be kept under
double lock security. If you wish to change the storage of your
controlled substances (location, etc.) you must notify the DEA.
5/1/2018 20
DEA Audits of Researchers Darri Scalzo, Research Compliance Officer Kim Murphy, IACUC Compliance Analyst
DEA Unscheduled Audit Process Can the disposition of drugs be traced from
purchase records and/or biennial inventory to current day?
Are there discrepancies in amounts, missing or inaccurate records, storage issues, etc.?
Each violation cited can result in letters of admonition, fines, or revocation of license.
We will be there during the audit to assist you!
5/1/2018 21
DEA Audits of Researchers Darri Scalzo, Research Compliance Officer Kim Murphy, IACUC Compliance Analyst
Questions? Contact Research Compliance if you would like
a review of your records to be sure you are ready for an audit.
Darri Scalzo (DLScalzo@uams.edu) or 686-8062Kimberly Murphy (KJMurphy@uams.edu) or 686-6340
5/1/2018 22
DEA Audits of Researchers Darri Scalzo, Research Compliance Officer Kim Murphy, IACUC Compliance Analyst
BrowZineSusan Steelman, MLISHead of Education & Research ServicesUAMS Library
Awareness Tool Find & Track Favorite eJournals
Multiple Platforms/DevicesWeb iOSAndroid
Desktop / Tablet / Phone5/1/2018 23
5/1/2018 24
BrowZineSusan Steelman, MLISHead of Education & Research ServicesUAMS Library
5/1/2018 25
BrowZineSusan Steelman, MLISHead of Education & Research ServicesUAMS Library
BrowZineSusan Steelman, MLISHead of Education & Research ServicesUAMS Library
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5/1/2018 27
BrowZineSusan Steelman, MLISHead of Education & Research ServicesUAMS Library
5/1/2018 28
Embargo Reminders
BrowZineSusan Steelman, MLISHead of Education & Research ServicesUAMS Library
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4 Bookcases
16 Shelves
64 JournalTitles
BrowZineSusan Steelman, MLISHead of Education & Research ServicesUAMS Library
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Life Story Not Required
Live Demo?
Susan Steelman 686-6737
scsteelman@uams.edu
E&RS 686-6734
LibraryReferenceDesk@uams.edu
BrowZineSusan Steelman, MLISHead of Education & Research ServicesUAMS Library
Library and Budget CutsJan K. Hart, MLS, Ed.DUAMS Library Director
Personnel Associate Provost for Library and Student
ServicesNadia Lalla
Library Systems Loretta Edwards
Highest paid librarian; highest paid staff person
5/1/2018 31
Flat Budget Resource Cuts - KeepersDatabases
Web of Science, Clinical Key, SciFinder Scholar, Ovid Medline, Cochrane databases; UptoDate
Journals Packages Nature; Elsevier renegotiate,
eBooks integrated in curriculum. AccessMedicine, AccessPharmacy,
etc. Stat!Ref
5/1/2018 32
Library and Budget CutsJan K. Hart, MLS, Ed.DUAMS Library Director
Flat Budget Resource Cuts – LossesDatabases
Several smaller databases
Journals losses mix of cost, cost per use, how many uses
eBooks losses w/o connection to our mission
BioMed CentralWill happen across the year
5/1/2018 33
Library and Budget CutsJan K. Hart, MLS, Ed.DUAMS Library Director
Flat Budget Resources - Fewer but tailored to UAMS Library Advisory Committee Colleges Groups like RESIN Clinical Mission Website Liaisons
5/1/2018 34
Library and Budget CutsJan K. Hart, MLS, Ed.DUAMS Library Director
Consortium licensing UA System – Elsevier Oklahoma – Stat!Ref SCAMeL – Nature
Keeping ILL ‘free’ up to $15? SCAMeL, NLM, and Texas repository
Providing alternatives Browzine
5/1/2018 35
Library and Budget CutsJan K. Hart, MLS, Ed.DUAMS Library Director
Flat Budget Resources - Strategies Awareness Promote full functionality Provide educational sessions Create materials to support greater use Publicize Gather comments, recommendations
5/1/2018 36
Library and Budget CutsJan K. Hart, MLS, Ed.DUAMS Library Director
Jan Hart, Library Director501-686-6751
hartjanicek@uams.edu
Susan Steelman, Head, Education/Research Services501-686-6737
steelmansusanc@uams.edu
Matthew Windsor, Head, Collection Managementmwindsor@uams.edu
501-686-67495/1/2018 37
Questions? Comments?
Library and Budget CutsJan K. Hart, MLS, Ed.DUAMS Library Director
TRACKS Portal 8.0 – Visual Changes Rebecca Nickleson, ORIS Director
TRACKS Grants and COI is being updated to Portal 8.0. Behind the scene changes to enhance
performance.
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Current Portal Portal 8.0
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TRACKS Portal 8.0 – Visual Changes Rebecca Nickleson, ORIS Director
Current Portal Portal 8.0
5/1/2018 40
TRACKS Portal 8.0 – Visual Changes Rebecca Nickleson, ORIS Director
Current Portal Portal 8.0
5/1/2018 41
TRACKS Portal 8.0 – Visual Changes Rebecca Nickleson, ORIS Director
Next RESIN
Next RESIN (after summer break) September 4, 2018 @ 12:00 p.m. Location - Walton Auditorium, Winthrop P.
Rockefeller Cancer Institute, 10th floor All RESIN presentations archived on the UAMS
Research website http://www.uams.edu/research/RESIN_Achive.asp
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